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FINASTERIDE 5 MG FILM-COATED TABLET

Active substance(s): FINASTERIDE

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PACKAGE LEAFLET

1

Package leaflet: Information for the user
Finasteride 5 mg Film-coated Tablet
Finasteride
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet
1.
What FINASTERIDE is and what it is used for
2.
What you need to know before you take FINASTERIDE
3.
How to take FINASTERIDE
4.
Possible side effects
5.
How to store FINASTERIDE
6.
Contents of the pack and other information

1.

What FINASTERIDE is and what it is used for

Finasteride belongs to the group of medicines called 5-alpha reductase inhibitors.
They act by reducing the size of the prostate gland in men.
Finasteride is used in the treatment and control of benign (i.e., non-cancerous) enlargement of the prostate
(benign prostatic hyperplasia - BPH). It causes shrinkage of the enlarged prostate, improves urinary flow and
symptoms caused by BPH, and reduces the risk of you developing a sudden inability to pass urine (known as
acute urinary retention) and the need for surgery.

2.

What you need to know before you take FINASTERIDE

Do not take FINASTERIDE:
if you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
if you are a woman (see also under ‘Pregnancy and breast-feeding’).
if you are a child.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking FINASTERIDE.
- If you have a large amount of residual urine in your bladder after urinating and/or severely reduced urinary
flow, you should be closely monitored for narrowing of the urinary tract.
- If you have impaired liver function, the level of finasteride in your blood may be increased.
- If your sexual partner is or may potentially be pregnant, you should avoid exposing her to your semen
which could contain a tiny amount of the drug.
- If you have a PSA test (test used to detect prostate cancer), tell your doctor that you are taking finasteride.
Finasteride can affect the blood levels of the substance being tested, PSA.
Tell your doctor if any of the above applies to you now or in the past.
You should promptly report to your doctor any changes in your breast tissue such as lumps, pain,
enlargement of the breast tissue or nipple discharge as these may be signs of a serious condition, such as
breast cancer.
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Other medicines and FINASTERIDE
Finasteride does not usually interfere with other medicines. No significant drug interactions have been
identified.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
FINASTERIDE with food and drink
Finasteride can be taken with or without food.
Pregnancy and breast-feeding
FINASTERIDE is only intended for men.
Women who are or may potentially be pregnant should not handle finasteride tablets especially if broken or
crushed. If finasteride is absorbed through the skin or taken by mouth by women pregnant with a male
foetus, the child may be born with malformed genital organs.
When the patient’s sexual partner is or may become pregnant, the patient should either avoid exposure of his
partner to semen (e.g. by use of a condom) or discontinue treatment with finasteride. If a woman who is
pregnant comes into contact with Finasteride, a doctor should be consulted.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Driving and using machines
There is no information to suggest that finasteride affects the ability to drive and use machines.
FINASTERIDE contains lactose
If you have been told by your doctor that you have intolerance to some sugars contact your doctor before
taking this medicinal product.

3.

How to take FINASTERIDE

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
The recommended dose is one tablet daily (equivalent to 5 mg finasteride).
The film-coated tablets can either be taken on an empty stomach or with a meal. The film-coated tablets
should be swallowed whole and should not be divided or crushed.
Although early improvement may be seen, treatment for at least six months may be necessary to assess
whether a beneficial response has been achieved.
Your doctor will tell you how long you should continue to take FINASTERIDE. Do not interrupt treatment
early or the symptoms may come back.
Patients with impaired liver function
There is no experience of the use of finasteride in patients with impaired liver function (see also ‘Warnings
and precautions‘).
Patients with impaired kidney function
No dosage adjustment is required. The use of Finasteride in patients who have to undergo haemodialysis has
not been investigated yet.
Elderly patients
No dosage adjustment is required.
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Please speak to your doctor or pharmacist if you feel that the effects of FINASTERIDE is too strong or too
weak.
If you take more FINASTERIDE than you should
If you have taken more tablets than you were told to, or if someone else has taken any tablets, contact
accident and emergency department of your nearest hospital. Take any left over tablets or empty box with
you for easier identification.
If you forget to take FINASTERIDE
If you forget to take a dose of FINASTERIDE, you can take it as soon as you remember unless it is time for
the next dose, in which case you should continue with your medication as prescribed. Do not take a double
dose to make up for a forgotten dose.
If you stop taking FINASTERIDE
Do not stop taking FINASTERIDE unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
For the assessment of side effects, the following descriptions of frequency have been used:
Very common – occur in more than 1 in 10 patients
Common – occur in more than 1 in 100 patients, but in less than 1 in 10 patients
Uncommon – occur in less than 1 in 100 patients, but in more than 1 in 1000 patients
Rare – occur in less than 1 in 1000 patients, but in more than 1 in 10000 patients
Very rare – occur in less than 1 in 10000 patients, including isolated reports
The most common side effects are impotence and decreased sexual drive. These effects normally occur at the
start of the treatment but do not usually last long in the majority of patients if treatment continues.
Investigations
Common: decreased volume of ejaculate
Cardiac disorders
Unknown: palpitation
Skin and subcutaneous tissue disorders
Uncommon: rash
Unknown: pruritus, urticaria
Immune system disorders
Unknown: hypersensitivity reactions including swelling of the lips and face
Hepatobiliary disorders
Unknown: increased hepatic enzymes
Reproductive system and breast disorders
Common: impotence
Uncommon: ejaculation disorder, breast tenderness, breast enlargement
Unknown: testicular pain, erectile dysfunction which may continue after discontinuation of treatment;

male infertility and/or poor seminal quality. Normalization or improvement of seminal quality has
been reported after discontinuation of finasteride.

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Psychiatric disorders
Common: decreased libido

Unknown: depression

Investigations
Common: decreased volume of ejaculate.
Finasteride may affect the result of PSA-laboratory test.
You should promptly report to your doctor any changes in your breast tissue such as lumps, pain,
enlargement or nipple discharge as these may be signs of a serious condition, such as breast cancer.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store FINASTERIDE

Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the label after Exp.The expiry date refers to
the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What FINASTERIDE contains
The active substance is Finasteride. One film-coated tablet contains 5 mg of finasteride.
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose , starch pregelatinized (1500), sodium starch
glycolate (type A), docusate sodium, magnesium stearate.
Film coating: hypromellose (E464), titanium dioxide (E171), indigo carmine aluminium lake (E132), talc,
iron oxide yellow (E172).
What FINASTERIDE looks like and contents of the pack
Film-coated Tablet.
Blue colour, round film coated tablets, debossed with ‘H’ on one side and ‘37’ on the other side.
Finasteride tablets are available in blister packs containing 15, 28, 30, 50, 60, 90, 98 or 100 film-coated
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
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Bluefish Pharmaceuticals AB,
Torsgatan 11, Stockholm, SE-111 23
Sweden

Manufacturer
Bluefish Pharmaceuticals AB,
Torsgatan 11, Stockholm, SE-111 23
Sweden

This leaflet was last revised in 08/2013.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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